Is Human normal immunoglobulin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 16 valid registrations of Human normal immunoglobulin, including CUVITRU 200MG/ML INJECTION (200 mg/ml, Solution for injection, SAR 448.30); HYQVIA 100MG/ML SOLUTION FOR INFUSION (10 %, Solution for infusion, SAR 1120.70); Hizentra 1 g per 5 ml PFS (200 mg/ml, Solution for injection, SAR 444.40); Hizentra 1 g per 5 ml vial (200 mg/ml, Solution for injection, SAR 444.40); Hizentra 10 g per 50 ml vial (200 mg/ml, Solution for injection, SAR 4444.25).

Is Human normal immunoglobulin authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Human normal immunoglobulin: Kiovig, Flebogamma DIF (previously Flebogammadif), Privigen, Hizentra, HyQvia, Deqsiga.

Are there safety signals or safety updates for Human normal immunoglobulin?

EMA PRAC: 5 entries (latest 2018-07-12).

Active substance

Human normal immunoglobulin

SFDA 17
EMA 6
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CUVITRU 200MG/ML INJECTION	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 448.30	Biological · Prescription	Baxalta Innovations GmbH	Valid
CUVITRU 200MG/ML INJECTION	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 896.55	Biological · Prescription	Baxalta Innovations GmbH	Valid
CUVITRU 200MG/ML INJECTION	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 1793.10	Biological · Prescription	Baxalta Innovations GmbH	Valid
CUVITRU 200MG/ML INJECTION	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 3586.25	Biological · Prescription	Baxalta Innovations GmbH	Valid
HYQVIA 100MG/ML SOLUTION FOR INFUSION	10 %	Solution for infusion · Subcutaneous use	1 Vial	SAR 1120.70	Biological · Prescription	Baxalta Innovations GmbH	Valid
HYQVIA 100MG/ML SOLUTION FOR INFUSION	10 %	Solution for infusion · Subcutaneous use	1 Vial	SAR 2241.40	Biological · Prescription	Baxalta Innovations GmbH	Valid
HYQVIA 100MG/ML SOLUTION FOR INFUSION	10 %	Solution for infusion · Subcutaneous use	1 Vial	SAR 4482.80	Biological · Prescription	Baxalta Innovations GmbH	Valid
HYQVIA 100MG/ML SOLUTION FOR INFUSION	10 %	Solution for infusion · Subcutaneous use	1 Vial	SAR 8965.60	Biological · Prescription	Baxalta Innovations GmbH	Valid
HYQVIA 100MG/ML SOLUTION FOR INFUSION	10 %	Solution for infusion · Subcutaneous use	1 Vial	SAR 13448.40	Biological · Prescription	Baxalta Innovations GmbH	Valid
Hizentra 1 g per 5 ml PFS	200 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 444.40	Biological · Prescription	CSL BEHRING	Valid
Hizentra 1 g per 5 ml vial	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 444.40	Biological · Prescription	CSL BEHRING	Valid
Hizentra 10 g per 50 ml vial	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 4444.25	Biological · Prescription	CSL BEHRING	Valid
Hizentra 2 g per 10 ml PFS	200 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 888.85	Biological · Prescription	CSL BEHRING	Valid
Hizentra 2 g per 10 ml Vial	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 888.85	Biological · Prescription	CSL BEHRING	Valid
Hizentra 4 g per 20 ml PFS	200 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 1777.65	Biological · Prescription	CSL BEHRING	Valid
Hizentra 4 g per 20 ml Vial	200 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 1777.65	Biological · Prescription	CSL BEHRING	Valid
Liv-Gamma	50 mg/ml	Solution for infusion · Intravenous use			Biological · Prescription	SK Plasma Co. Ltd	Conditional Approval

Indications — CHI Daman Drug Formulary

MYOSITIS; OPTIC NEURITIS

EMA European Union — centrally authorised medicines

Kiovig Takeda Manufacturing Austria AG · Authorised · authorised 19 Jan 2006 · ATC J06BA02

Therapeutic indication (EMA)

Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS and recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease; multifocal motor neuropathy (MMN).

Flebogamma DIF (previously Flebogammadif) Instituto Grifols S.A. · Authorised · authorised 23 Jul 2007 · ATC J06BA02

Therapeutic indication (EMA)

Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease.

Privigen CSL Behring GmbH · Authorised · authorised 24 Apr 2008 · ATC J06BA02

Therapeutic indication (EMA)

Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency (PID) syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain-Barré syndrome; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.

Hizentra CSL Behring GmbH · Authorised · authorised 14 Apr 2011 · ATC J06BA01

Therapeutic indication (EMA)

Replacement therapy in adults, children and adolescents (0-18 years) in: - Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0-18 years): - Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

HyQvia Baxalta Innovations GmbH · Authorised · authorised 16 May 2013 · ATC J06BA01

Therapeutic indication (EMA)

Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production. Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in: Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

Deqsiga Takeda Manufacturing Austria AG · Authorised · authorised 2 May 2025 · ATC J06BA02

Therapeutic indication (EMA)

Replacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production. - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L.*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesImmunomodulation in adults, children and adolescents (0 to 18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome. - Kawasaki disease (in conjunction with acetylsalicylic acid; see section 4.2). - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). - Multifocal Motor Neuropathy (MMN).

Safety signals and safety-related labeling changes

EMA PRAC 12 Jul 2018 PRAC signal: Lupus-like syndrome and related terms
Action for MAH: update of the product information: Yes
EMA PRAC 12 Apr 2018 PRAC signal: Lupus-like syndrome and related terms
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2017 PRAC signal: Lupus-like syndrome and related terms
Action for MAH: update of the product information: No
EMA PRAC 17 Mar 2016 PRAC signal: Posterior reversible encephalopathy syndrome (PRES)
Action for MAH: update of the product information: No
EMA PRAC 6 Nov 2015 PRAC signal: Posterior reversible encephalopathy syndrome (PRES)
Action for MAH: update of the product information: No

All safety entries for human normal immunoglobulin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.